[HTML][HTML] Stabilizing vaccines via drying: Quality by design considerations
Z Ghaemmaghamian, R Zarghami, G Walker… - Advanced Drug Delivery …, 2022 - Elsevier
Pandemics and epidemics are continually challenging human beings' health and imposing
major stresses on the societies particularly over the last few decades, when their frequency …
major stresses on the societies particularly over the last few decades, when their frequency …
[HTML][HTML] An examination of process models and model risk frameworks for pharmaceutical manufacturing
T O'Connor, S Chatterjee, J Lam… - International Journal of …, 2024 - Elsevier
Process models are a growing tool for pharmaceutical manufacturing process design and
control. The Industry 4.0 paradigm promises to increase the amount of data available to …
control. The Industry 4.0 paradigm promises to increase the amount of data available to …
Digital twin of mRNA-based SARS-COVID-19 vaccine manufacturing towards autonomous operation for improvements in speed, scale, robustness, flexibility and real …
A Schmidt, H Helgers, FL Vetter, A Juckers, J Strube - Processes, 2021 - mdpi.com
Supplying SARS-COVID-19 vaccines in quantities to meet global demand has a bottleneck
in manufacturing capacity. Assessment of existing mRNA (messenger ribonucleic acid) …
in manufacturing capacity. Assessment of existing mRNA (messenger ribonucleic acid) …
Digital twin for lyophilization by process modeling in manufacturing of biologics
LS Klepzig, A Juckers, P Knerr, F Harms, J Strube - Processes, 2020 - mdpi.com
Lyophilization stabilizes formulated biologics for storage, transport and application to
patients. In process design and operation it is the link between downstream processing and …
patients. In process design and operation it is the link between downstream processing and …
Recommended best practices for lyophilization validation—2021 part I: process design and modeling
F Jameel, A Alexeenko, A Bhambhani, G Sacha… - AAPS …, 2021 - Springer
Abstract This work describes lyophilization process validation and consists of two parts. Part
I focuses on the process design and is described in the current paper, while part II is devoted …
I focuses on the process design and is described in the current paper, while part II is devoted …
LyoPRONTO: an open-source lyophilization process optimization tool
G Shivkumar, PS Kazarin, AD Strongrich… - AAPS …, 2019 - Springer
This work presents a new user-friendly lyophilization simulation and process optimization
tool, freely available under the name LyoPRONTO. This tool comprises freezing and primary …
tool, freely available under the name LyoPRONTO. This tool comprises freezing and primary …
Advanced process analytical technology in combination with process modeling for endpoint and model parameter determination in lyophilization process design and …
A Juckers, P Knerr, F Harms, J Strube - Processes, 2021 - mdpi.com
Lyophilization is widely used in the preservation of thermolabile products. The main
shortcoming is the long processing time. Lyophilization processes are mostly based on a …
shortcoming is the long processing time. Lyophilization processes are mostly based on a …
Best Practices and guidelines (2022) for Scale-up and Tech transfer in Freeze-Drying based on Case Studies. Part 1: challenges during Scale up and transfer
S Tchessalov, E Shalaev, B Bhatnagar, S Nail… - AAPS …, 2022 - Springer
The freeze-drying process scale-up and transfer remain a complicated and non-uniform
practice. We summarized inefficient and good practices in these papers and provided some …
practice. We summarized inefficient and good practices in these papers and provided some …
Lyophilization scale-up to industrial manufacturing: A modeling framework including probabilistic success prediction
Scaling-up a lyophilization cycle to the manufacturing scale successfully at the first pass is of
crucial importance to the bio-pharmaceutical community in order to save expensive and …
crucial importance to the bio-pharmaceutical community in order to save expensive and …
Best practices and guidelines (2022) for scale-up and technology transfer in freeze drying based on case studies. Part 2: past practices, current best practices, and …
S Tchessalov, E Shalaev, B Bhatnagar, S Nail… - AAPS …, 2023 - Springer
Scale-up and transfer of lyophilization processes remain very challenging tasks considering
the technical challenges and the high cost of the process itself. The challenges in scale-up …
the technical challenges and the high cost of the process itself. The challenges in scale-up …